What type of changes does the CBE-30 submission report to the FDA?

The CBE-30 submission refers to a specific type of supplement to an existing drug application that allows a manufacturer to make certain changes regarding the production or formulation of a drug product. This submission is designed to address changes that are deemed to have a moderate potential to adversely impact the quality of the drug. These changes may include modifications to the manufacturing process, tests, or specifications.

The rationale behind the CBE-30 is that while the changes are significant enough to warrant FDA notification, they do not necessitate extensive clinical trials or a full resubmission of the application. The FDA seeks to ensure that any alterations still maintain the drug's quality, safety, and efficacy, thus requiring a mechanism like the CBE-30 to streamline the reporting and regulatory process for moderate-risk changes that still need oversight.

In summary, choosing the option that highlights changes with moderate potential to adversely affect quality captures the essence of what the CBE-30 submission entails. This reflects an appropriate level of regulatory scrutiny while allowing manufacturers to proceed with necessary updates more efficiently.